Bayer withholds Trasylol study
The Federal Drug Administration's Cardiovascular and Renal Drug Advisory Committee met on September 21, 2006 to review current Trasylol study results regarding Trasylol side effects. The committee evaluated the published studies and the global safety and efficacy database submitted by Bayer. After reviewing all the data that was made available, the FDA committee decided that there was not enough evidence to require an updated warning on Trasylol's labeling and agreed that the published data supported an acceptable safety level for Trasylol.
On September 29, 2006, days after the committee meeting, the FDA received new data from Bayer regarding an additional Trasylol study that it had failed to reveal prior to the committee meeting. It was learned that Bayer had commissioned an observational study involving 67,000 patients who were given Trasylol (aprotinin). Preliminary review of the new study data shows a potential for increased risk of Trasylol side effects including heart failure, stroke, kidney failure, and death. There is conflicting information as to why Bayer failed to disclose this important Trasylol study during the FDA's Committee meeting on September 21, 2006.
The FDA issued a public health advisory on September 29, 2006, stating that it had received new information regarding a Trasylol study that Bayer had not disclosed prior to the committee meeting. Analysis of the Trasylol study data is ongoing at the FDA, however the initial review of the study shows aprotinin may be associated with "increased risk for death, kidney failure, congestive heart failure and stroke."
